The following data is part of a premarket notification filed by Oco Biomedical with the FDA for I-mini Dental Implant.
| Device ID | K080115 |
| 510k Number | K080115 |
| Device Name: | I-MINI DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OCO BIOMEDICAL 21525 RIDGETOP CIRCLE SUITE 240 Sterling, VA 20166 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls OCO BIOMEDICAL 21525 RIDGETOP CIRCLE SUITE 240 Sterling, VA 20166 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-16 |
| Decision Date | 2008-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7853016OB0 | K080115 | 000 |
| D7853008CB0 | K080115 | 000 |
| D7853008OB0 | K080115 | 000 |
| D7853010CB0 | K080115 | 000 |
| D7853010OB0 | K080115 | 000 |
| D7853012CB0 | K080115 | 000 |
| D7853012OB0 | K080115 | 000 |
| D7853014CB0 | K080115 | 000 |
| D7853014OB0 | K080115 | 000 |
| D7853016CB0 | K080115 | 000 |
| D7853018CB0 | K080115 | 000 |